The Development of the HOPE Act

In 1984 & 1988, the National Organ Transplant Act, made the following provision: 42 U.S.C. 274(b) Sect 372(b):

“…requires the OPTN to adopt and use standards for preventing the acquisition of organs from individuals known to be infected with HIV.”

Based on a study in 2011 (Boyarsky/Segev), it is estimated there is a potential of 500-600 HIV-infected (HIV+) organ donors per year.

The HIV Organ Policy Equity (HOPE Act) was conceived (Boyarsky/Segev) to revise the National Organ Transplant Act and was supported by dozens of professional medical, transplant, and patient organizations.

In 2013, president Obama signed the HOPE Act.

Mandates of the HOPE Act

The Secretary will revise the current regulations, specifically 42 Code of Federal Regulations (CFR) 121.6.

The Secretary will publish the research criteria for HIV+ to HIV+ transplant.

The OPTN will revise the standards for the acquisition and transportation of donated HIV infected organs.

Those regulatory revisions were to be made within two years by November 21, 2015.

On June 8, 2015, the Final Rule was published with the following regulatory amendment:

“…, this regulation includes new requirements that organs from individuals infected with HIV may be transplanted only into individuals who are infected with HIV and who are participating in clinical research approved by an institutional review board…in accordance with the research criteria to be published by the Secretary.

Requirements for HOPE Act Research Studies

In November 2015, guidelines for conducting HIV transplant research were released allowing any center* with an IRB-approved protocol to perform HIV to HIV transplants.

Several transplant programs are conducting studies.

These scientific studies will be evaluated for standards of quality.

*John Hopkins is NIH funded to study HIV+ donors and HIV-to-HIV transplants and are running a national multi-center program of HIV-to-HIV transplants.

Editor: Hedi Aguiar RN, MSN, Director of Programs and Communications, The Alliance, haguiar@odt-alliance.org.
This Education Corner is available for download. The Alliance grants permission for the distribution and reproduction of this educational communication.